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FDA Approves Upadacitinib for Adults with Active Psoriatic Arthritis

The JAK inhibitor therapy was supported by a pair of phase 3 trials showing improved disease control in treated patients.

The US Food and Drug Administration (FDA) has approved once-daily 15 mg upadacitinib (RINVOQ) for the treatment of adults with active psoriatic arthritis (PsA) who previously did not receive adequate response nor tolerance to tumor necrosis factor (TNF) inhibitor therapy.

The approval granted to AbbVie marks the second indication appointed to the selective Janus kinase (JAK) inhibitor, after an initial approval for adults with rheumatoid arthritis in 2019.

Earlier this year, AbbVie had announced that the FDA would delay deliberation on the drug application's original PDUFA date in late June.

Upadacitinib’s benefit for adults with PsA was supported by data from a pair of phase 3 clinical trials in the SELECT-PsA clinical program. In SELECT-PsA 1, a investigators conducted a multicenter, randomized, double-blind, active comparator- and placebo-controlled trial to assess the safety and efficacy of upadacitinib versus placebo and adalimumab in adults with moderately to severely active psoriatic arthritis previously treated with ≥1 non-biologic disease-modifying antirheumatic drug (DMARD).

Patients were randomized to either 15 mg or 30 mg upadacitinib, 40 mg adalimumab, or placebo, dosed every other week until week 24, then either 15 mg or 30 mg upadacitinib. Investigators sought a primary endpoint of percentage of upadacitinib-treated patients achieved ACR20 response after 12 weeks versus placebo.

SELECT-PsA 2 was a similarly-designed trial that compared such adult patients randomized to either 15 mg or 30 mg upadacitinib, or placebo, followed by either treatment dose at week 24. Investigators sought a primary endpoint of percentage of patients achieving ACR20 after 12 weeks versus placebo.

Upadacitinib reached the primary endpoint in both trials, with 71% and 57% of trial patients taking 15 mg upadacitinib reaching ACR20, respectively, versus 36% and 24% of placebo patients.

Investigators observed a consistent safety profile in patients with active PsA treated with 15 mg upadacitinib as was observed in treated patients with rheumatoid arthritis. Through 24 weeks of placebo-controlled assessment, the most common adverse events associated with 15 mg treatment included upper respiratory tract infection and blood creatine phosphokinase elevations.

Upadacinitib is associated with increased risk of serious side effects including serious infections, increased risk of death in patients ≥50 years old with ≥1 cardiovascular risk factor, cancer and immune system conditions, cardiovascular events, and blood clots.

SELECT-PsA 1 lead investigators Professor Iain McInnes, of the University of Glasgow, noted that many adults with active psoriatic arthritis still “struggle to find a treatment option that helps them lower their disease activity.”

“With this FDA approval, RINVOQ has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals,” McInnes said.